“This substantial update of our Phase 1/1b clinical data on RXDX-105
provides compelling evidence of its potent anti-tumor activity with
promising durability and acceptable safety in patients with RET-fusion
positive tumors,” said Pratik Multani, M.D., Chief Medical Officer of
Ignyta. “With approximately 500-fold higher potency against RET than
VEGFR2 in vitro, RXDX-105 has the potential to address a critical
unmet medical need in RET-positive patients for whom the clinical
utility of multikinase inhibitors with both RET and VEGFR activity is
constrained by safety liabilities and limited efficacy. We look forward
to the continuation of the study to further explore the safety and
efficacy of RXDX-105.”

As of the November 2016, data cut-off, the findings showed:

Safety

A total of 91 patients with a range of solid tumors have been treated in
the Phase 1/1b clinical trial, with 55 patients treated in the Phase 1
study and 36 patients treated in the Phase 1b study.

RXDX-105 continues to demonstrate a safety profile similar to what has
been previously reported: across both studies, the most common
treatment-related adverse events (>10% incidence) were rash (31%),
fatigue (22%), diarrhea (20%), nausea (18%), hypophosphatemia (14%),
vomiting (14%), muscle spasms (13%), and decreased appetite (10%);

The majority of treatment-related adverse events were Grade 1 or
2, and were reversible with dose modification;

One patient experienced a Grade 3 drug reaction with eosinophilia
and systemic symptoms, in which the patient recovered with drug
discontinuation. One patient experienced Grade 3 rash complicated
by fatal alveolar hemorrhage. No other treatment-related Grade 4
or higher events were observed.

Of the 36 patients treated in the Phase 1b study, 35 had RET or BRAF
molecular alterations.

Nine RET inhibitor-naïve patients (n = 8 in the Phase 1b cohort; n = 1
in the Phase 1 cohort) with RET fusion-positive tumors were treated at a
daily dose of 275 mg or 350 mg in the fed state, and were evaluable for
response.

A preliminary ORR of 56% was observed in patients with RET
fusion-positive solid tumors who were RET inhibitor-naïve (five out of
nine treated patients had a RECIST response);

Of the five patients demonstrating a RECIST response, one patient
with metastatic colorectal cancer (mCRC) achieved a complete
response; three patients, all with non-small cell lung cancer
(NSCLC), achieved a partial response; and one patient with NSCLC
had an unconfirmed partial response;

Among the seven patients with RET fusion-positive NSCLC who were
RET inhibitor-naïve, three achieved a partial response and one
achieved an unconfirmed response (a second scan had not been
obtained at the date of data cutoff), for a preliminary ORR of 57%;

Duration of response to RXDX-105 ranged from 2+ to 7+ months, with all
responder patients currently continuing on treatment in active
response; median duration of response, therefore, has not yet been
determined;

These data confirm that RXDX-105 is active across a range of different
histologies, with confirmed RECIST responses now observed in medullary
thyroid cancer, NSCLC, and mCRC, and across a range of RET molecular
alterations, including the M918T point mutation, and CCDC6-, EML4-,
and PARD3-RET fusions.

Among the remaining patients treated in Phase 1b who were either RET
fusion-positive and received prior RET inhibitor treatments (n = 4) or
had BRAF molecular alterations (n = 23), durable disease control but no
objective responses have been observed to date.

Based on the promising efficacy data observed thus far in patients with
RET fusion-positive solid tumors who are RET inhibitor-naïve, this
population will remain the primary focus of future development of
RXDX-105. Enrollment in the Phase 1b study is ongoing to further explore
the safety and efficacy of RXDX-105 in various molecular baskets at
several doses.

About Ignyta, Inc.

Blazing a New Future for Patients with Cancer™

At Ignyta, we work tirelessly on behalf of patients with cancer to offer
potentially life-saving, precisely targeted therapeutics (Rx) guided by
companion diagnostic (Dx) tests. Our integrated Rx/Dx strategy allows us
to enter uncharted territory, illuminating the molecular drivers of
cancer and quickly advancing treatments to address them. This approach
embraces even those patients with the rarest cancers, who have the
highest unmet need and who may otherwise not have access to effective
treatment options. With our pipeline of potentially first-in-class and
best-in-class precision medicines, we are pursuing the ultimate goal of
not just shrinking tumors, but eradicating cancer relapse and recurrence
in precisely defined patient populations.

This press release contains forward-looking statements about Ignyta as
that term is defined in Section 27A of the Securities Act of 1933 and
Section 21E of the Securities Exchange Act of 1934. Statements in this
press release that are not purely historical are forward-looking
statements. Such forward-looking statements include, among other things,
references to the results of the Phase 1/1b clinical study of RXDX-105
and the development and potential of Ignyta's product candidates. Actual
results could differ from those projected in any forward-looking
statements due to numerous factors. Such factors include, among others,
the inherent uncertainties associated with developing new products or
technologies and operating as a development stage company; Ignyta's
ability to develop, initiate or complete preclinical studies and
clinical trials for, obtain approvals for and commercialize any of its
product candidates; changes in Ignyta's plans to develop and
commercialize its product candidates; the potential for final results of
the ongoing clinical trials of RXDX-105 or other product candidates, or
any future clinical trials of RXDX-105 or other product candidates, to
differ from preliminary or expected results; Ignyta's ability to raise
any additional funding it will need to continue to pursue its business
and product development plans; regulatory developments in the United
States and foreign countries; Ignyta's ability to obtain and maintain
intellectual property protection for its product candidates; the risk
that orphan drug exclusivity may not effectively protect a product from
competition and that such exclusivity may not be maintained; the
potential for Ignyta to fail to maintain the CAP accreditation and CLIA
certification of its diagnostic laboratory; the loss of key scientific
or management personnel; competition in the industry in
which Ignyta operates; and market conditions. These forward-looking
statements are made as of the date of this press release,
and Ignyta assumes no obligation to update the forward-looking
statements, or to update the reasons why actual results could differ
from those projected in the forward-looking statements. Investors should
consult all of the information set forth herein and should also refer to
the risk factor disclosure set forth in the reports and other documents
Ignyta files with the SEC available at www.sec.gov,
including without limitation Ignyta's Annual Report on Form 10-K for the
year ended December 31, 2015, and subsequent Quarterly Reports on Form
10-Q.

PharmiWeb.com is Europe's leading industry-sponsored portal for the Pharmaceutical sector, providing the latest jobs, news, features and events listings.
The information provided on PharmiWeb.com is designed to support, not replace, the relationship that exists between a patient/site visitor and his/her
physician.